Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma

Inclusion Criteria

• •Diagnosis of neuroblastoma
• •* Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
• •Persistent and/or refractory disease, with at least 1 of the following:
• •* Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
• •* Progressive disease after nonmyeloablative or myeloablative therapy
• •Recurrent disease, evidenced by any of the following:
• •* Biopsy-proven recurrent soft tissue disease
• •* Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
• •* Histologically confirmed bone marrow disease
• •* Progressive or stable disease after at least 1 prior standard salvage regime
• •No clinically significant pleural effusion
• •ECOG 0-1
• •Life expectancy \>= 12 weeks
• •Hepatitis A antibody negative
• •Hepatitis B surface antigen negative
• •* Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
• •Hepatitis C virus negative
• •No history of congenital or acquired coagulation disorder
• •Cardiac function normal by ECG
• •No dyspnea at rest
• •No exercise intolerance
• •Oxygen saturation at least 94% by pulse oximetry
• •DLCO greater than 60% of predicted
• •FEV1 greater than 70% of predicted
• •Negative pregnancy test
• •Skull-based bony lesions without space-occupying intracranial extension are allowed
• •No prior or concurrent intracranial metastatic disease to the brain parenchyma
• •Not pregnant or nursing
• •Fertile patients must use effective barrier contraception during and for at least 2 months after study
• •No prior hematologic malignancy (including leukemia or lymphoma)
• •No history of malignant hyperthermia
• •No prior or concurrent autoimmune disease
• •No positive direct Coombs testing
• •No history of ongoing or intermittent bowel obstruction
• •No active infection or other significant systemic illness
• •More than 2 weeks since prior fenretinide
• •More than 2 weeks since prior 13-cis-retinoic acid
• •More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
• •More than 2 weeks since prior interferons or interleukins
• •More than 2 weeks since prior cytokine-fusion proteins
• •More than 2 weeks since prior IV immunoglobulin (IVIG)
• •No prior interleukin-12
• •No concurrent cytokines
• •No concurrent fenretinide
• •No concurrent 13-cis-retinoic acid
• •No other concurrent immunomodulators, including:
• •* G-CSF and GM-CSF
• •* Interferons
• •* Other interleukins
• •* IVIG
• •More than 4 weeks since prior chemotherapy
• •No other unstable medical condition or critical illness that would preclude study participation
• •More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem cell transplantation:
• •No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation
• •More than 2 weeks since prior growth hormones
• •More than 4 weeks since prior systemic corticosteroids
• •More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral birth control pills)
• •No concurrent hormonal therapy (including oral birth control pills)
• •No concurrent growth hormones
• •No concurrent systemic corticosteroids, except for use in life-threatening complications
• •More than 4 weeks since prior radiotherapy
• •No prior solid organ transplantation
• •More than 4 weeks since prior investigational agents
• •No other concurrent investigational agents
• •No prior enrollment on COG-A3973, unless disease has progressed
• •No history of hemolytic anemia
• •Absolute neutrophil count at least 1,500/mm\^3 \[Note: Independent of growth factor or transfusion support\]
• •Platelet count at least 75,000/mm\^3 \[Note: Independent of growth factor or transfusion support\]
• •AST and ALT less than 2.5 times upper limit of normal
• •Bilirubin less than 2.0 mg/dL
• •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR creatinine normal
• •HIV negative
• •Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at least 30% by echocardiogram
• •No congestive heart failure
• •No uncontrolled cardiac arrhythmia